Why it was recalled
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Product description
StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide and United Kingdom
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0950-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 8, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 20-50 bottles/units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Phillips Co.
Original FDA data
Every field from FDA enforcement report D-0950-2017, exactly as published.
Show all FDA fields
- City
- Millerton
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 77526
- Address
- 311 Chikasaw Street
- Code information
- All lots remaining within expiry.
- Postal code
- 74750
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0950-2017
- Classification
- Class II
- Recalling firm
- Phillips Co.
- Product quantity
- 20-50 bottles/units
- Termination date
- Jul 20, 2020
- Reason for recall
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
- Distribution pattern
- Nationwide and United Kingdom
- Recall initiation date
- Jun 8, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 6, 2017